NDA Resubmitted to FDA for Camrelizumab + Rivoceranib for 1L Unresectable HCC Boosted by CARES-310 Leading OS Analysis
“Elevar’s timely resubmission of the NDA for the combination of camrelizumab and rivoceranib marks a critical milestone in our mission to bring a novel combination therapy for uHCC to patients and healthcare providers. HCC remains an area of significant unmet medical need,” said Dr. Saeho Chong, chief executive officer of Elevar Therapeutics. “This achievement would not have been realized without the extraordinary dedication of Elevar’s teams. We are eager to work with the FDA in the coming months as we focus on the commercialization of our combination therapy.” The resubmission is supported by the Phase 3 CARES-310 study landmark analysis presented during the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting on June 1, which reported median overall survival (mOS) of 23.8 months, the longest mOS for any treatment in a global Phase 3 trial for patients with uHCC, confirming the combination of camrelizumab and rivoceranib continued to show sustained long-term survival as a first-line treatment for uHCC.
Share:
More News
“The eNRGy study highlights that NRG1 fusions are an actionable therapeutic target and the importance of developing biomarker-driven therapies like zenocutuzumab,” said Debasish Roychowdhury, MD, Chief Technology Officer at Partner Therapeutics. “We are deeply grateful to the Merus team that designed, researched and developed zenocutuzumab, the eNRGy trial investigators, and
Pnina Fishman, CSO & Chairperson of Can-Fite BioPharma, commented: “We are pleased to offer this compassionate use program with Namodenoson for eligible patient in the US to address the unmet medical needs for pancreatic cancer. Initiating this program is another milestone achieved for Namodenoson, and concurrently to our ongoing Phase
“We are deeply disappointed by these results from our Phase 1 trial. Despite continuing to demonstrate differentiated safety as a more combinable ADC, updated efficacy data suggest that treatment with EO-3021 does not meet our bar for success and is insufficient to provide patients a competitive benefit-risk profile compared to
Søren Bregenholt, CEO of Alligator, commented: “The FDA’s recognition of HLX22/AC101’s potential with Orphan Drug Designation is a notable recognition. While Alligator’s is not directly involved in the development of HLX22/AC101, we continue to follow its progress as it potentially represents future income to Alligator.”
